Outcomes of paclitaxel-coated balloon angioplasty for in-stent calcified nodule: An optical coherence tomography study.

BACKGROUND: Paclitaxel-coated balloon (PCB) angioplasty emerges as an effective therapeutic option for in-stent restenosis (ISR). However, whether PCB angioplasty would be effective for in-stent calcified nodule (ISCN) lesions remain fully understood. This study aimed to evaluate the frequency and outcomes of ISCN in patients undergoing PCB angioplasty for ISR after second-generation drug-eluting stents (G2-DES) implantation. METHODS: This study enrolled 179 lesions (160 patients) undergoing PCB angioplasty for G2-DES restenosis with optical coherence tomography guidance. According to the presence of ISCN at the minimum lumen area, the lesions were divided into two groups: the ISCN (n = 16) and the non-ISCN groups (n = 163). The primary study endpoint was the cumulative 3-year incidence of target lesion failure (TLF; a composite of cardiac death, clinically driven target vessel revascularization, and definite stent thrombosis) on a lesion basis. RESULTS: ISCN was observed in 16 of 179 lesions (8.9%). Cumulative 3-year incidence of TLF was significantly higher in the ISCN group than in the non-CN group (85.3% vs. 16.9%, inverse probability weighted hazard ratio [HR] 4.46, 95% confidence intervals [CIs]: 2.42-8.22, p < 0.001). Risk factors associated with TLF were ISCN (HR 4.55, 95% CI: 1.56-13.3, p = 0.005), recurrent ISR (HR 2.82, 95% CI: 1.50-3.30, p = 0.001), and early ISR (HR 2.18, 95% CI: 1.21-3.92, p = 0.009). CONCLUSION: ISCN was observed in 8.3% of G2-DES restenosis. PCB angioplasty had little effect on ISCN lesions compared with non-ISCN lesions, suggesting the need for careful clinical follow-up of patients with ISCN lesions after PCB angioplasty.

Open-Label Randomized Trial Comparing Oral Anticoagulation With and Without Single Antiplatelet Therapy in Patients With Atrial Fibrillation and Stable Coronary Artery Disease Beyond 1 Year After Coronary Stent Implantation.

BACKGROUND: Despite recommendations in the guidelines and consensus documents, there has been no randomized controlled trial evaluating oral anticoagulation (OAC) alone without antiplatelet therapy (APT) in patients with atrial fibrillation and stable coronary artery disease beyond 1 year after coronary stenting. METHODS: This study was a prospective, multicenter, open-label, noninferiority trial comparing OAC alone to combined OAC and single APT among patients with atrial fibrillation beyond 1 year after stenting in a 1:1 randomization fashion. The primary end point was a composite of all-cause death, myocardial infarction, stroke, or systemic embolism. The major secondary end point was a composite of the primary end point or major bleeding according to the International Society on Thrombosis and Haemostasis classification. Although the trial was designed to enroll 2000 patients during 12 months, enrollment was prematurely terminated after enrolling 696 patients in 38 months. RESULTS: Mean age was 75.0±7.6 years, and 85.2% of patients were men. OAC was warfarin in 75.2% and direct oral anticoagulants in 24.8% of patients. The mean CHADS2 score was 2.5±1.2. During a median follow-up interval of 2.5 years, the primary end point occurred in 54 patients (15.7%) in the OAC-alone group and in 47 patients (13.6%) in the combined OAC and APT group (hazard ratio, 1.16; 95% CI, 0.79-1.72; P=0.20 for noninferiority, P=0.45 for superiority). The major secondary end point occurred in 67 patients (19.5%) in the OAC-alone group and in 67 patients (19.4%) in the combined OAC and APT group (hazard ratio, 0.99; 95% CI, 0.71-1.39; P=0.016 for noninferiority, P=0.96 for superiority). Myocardial infarction occurred in 8 (2.3%) and 4 (1.2%) patients, whereas stroke or systemic embolism occurred in 13 (3.8%) and 19 (5.5%) patients, respectively. Major bleeding occurred in 27 (7.8%) and 36 (10.4%) patients, respectively. CONCLUSIONS: This randomized trial did not establish noninferiority of OAC alone to combined OAC and APT in patients with atrial fibrillation and stable coronary artery disease beyond 1 year after stenting. Because patient enrollment was prematurely terminated, the study was underpowered and inconclusive. Future larger studies are required to establish the optimal antithrombotic regimen in this population. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01962545.

Five-Year Clinical Outcomes After Drug-Eluting Stent Implantation Following Rotational Atherectomy for Heavily Calcified Lesions.

BACKGROUND: Percutaneous coronary intervention for heavily calcified lesions requires rotational atherectomy (RA). Long-term clinical outcomes after drug-eluting stent (DES) implantation following (RA) for heavily calcified lesions remain unclear. We assessed 5-year clinical outcomes after DES implantation following RA.Methods and Results:Between March 2006 and September 2011, 219 consecutive patients with 219 lesions treated with DES following RA, were retrospectively enrolled. The cumulative 5-year incidence of target-lesion revascularization (TLR) and definite stent thrombosis (ST) were assessed. The cumulative incidence of TLR within (≤) the first year was 18.6%. Late TLR beyond (>) 1 year continued to occur at 1.9% per year without a decrease in the rate (5-year incidence, 26.0%). The cumulative incidence of definite ST at 30 days, 1 and 5 years was 0.9%, 2.3% and 2.9%, respectively. The annual rate of definite ST beyond 1 year was 0.15%. On multivariate analysis, the significant predictor of TLR within 1 year was use of first-generation DES (hazard ratio [HR], 2.09; 95% CI: 1.10-4.03, P=0.02) and that of TLR beyond 1 year was hemodialysis (HR, 3.29; 95% CI: 1.06-10.55, P=0.04). CONCLUSIONS: Late TLR beyond 1 year continued to occur up to 5 years at a constant annual incidence, whereas very late ST was rare. Careful long-term clinical follow-up is continually needed in patients who have already received DES following RA for heavily calcified lesions.

Incidence and Long-Term Clinical Impact of Late-Acquired Stent Fracture After Sirolimus-Eluting Stent Implantation in Narrowed Coronary Arteries.

The incidence and long-term clinical impact of stent fracture (SF) occurred beyond 1 year after sirolimus-eluting stent (SES) implantation remains unclear. From April 2004 to March 2008, 985 consecutive patients with 1,307 lesions were treated only with SES. Of these, 868 patients (88.1%) with 1,140 lesions underwent follow-up angiography within 1 year after the index procedure, and 646 patients (65.6%) with 872 lesions underwent it both within and beyond 1 year after the index procedure. According to the diagnosed timing of SF, we divided the patients into the 2 groups: early SF (<1 year after the index procedure) and late-acquired SF (>1 year after the index procedure). Early- and late-acquired SFs were observed in 64 of 868 patients (7.4%) and 66 of 1,140 lesions (5.8%); 12 of 646 patients (1.9%) and 12 of 872 lesions (1.4%), respectively. Cumulative 10-year incidence of clinically driven target lesion revascularization and definite stent thrombosis were numerically higher in the early- and late-acquired SF groups than in the non-SF group (41.6% vs 45.5% vs 19.0%; 8.0% vs 8.3% vs 2.0%, respectively). In conclusion, late-acquired SF after SES implantation occurred in 1.4% of lesions, which was lower than that of early SF. However, both early- and late-acquired SFs appeared to be associated with clinically driven target lesion revascularization and stent thrombosis during the long-term follow-up.

Impact of Sleep-Disordered Breathing on Long-Term Outcomes in Patients With Acute Coronary Syndrome Who Have Undergone Primary Percutaneous Coronary Intervention.

BACKGROUND: Sleep-disordered breathing (SDB) has been recognized as an important risk factor for cardiovascular diseases; however, the impact of SDB on long-term outcomes in patients with acute coronary syndrome has not been fully evaluated. METHODS AND RESULTS: We performed overnight cardiorespiratory monitoring of 241 patients with acute coronary syndrome who were successfully treated with primary percutaneous coronary intervention between January 2005 and December 2008. The presence of SDB was defined as apnea-hypopnea index ≥5 events per hour. The end point was incidence of major adverse cardiocerebrovascular events, defined as a composite of all-cause death, recurrence of acute coronary syndrome, nonfatal stroke, and hospital admission for congestive heart failure. Patients were followed for a median period of 5.6 years. Among the 241 patients who were finally enrolled, comorbidity of SDB with acute coronary syndrome was found in 126 patients (52.3%). The cumulative incidence of major adverse cardiocerebrovascular events was significantly higher in patients with SDB than in those without SDB (21.4% versus 7.8%, P=0.006). Multivariable analysis revealed that the presence of SDB was a significant predictor of major adverse cardiocerebrovascular events (hazard ratio 2.28, 95% CI 1.06-4.92; P=0.035). CONCLUSIONS: The study's results showed that the presence of SDB among patients with acute coronary syndrome following primary percutaneous coronary intervention is associated with a higher incidence of major adverse cardiocerebrovascular events during long-term follow-up.